Details for New Drug Application (NDA): 020753

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NDA 020753 describes AROMASIN, which is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. Additional details are available on the AROMASIN profile page.

The generic ingredient in AROMASIN is exemestane. There are fifteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the exemestane profile page.

Summary for 020753

Tradename:	AROMASIN
Applicant:	Pfizer
Ingredient:	exemestane
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020753

Mechanism of Action	Aromatase Inhibitors

Suppliers and Packaging for NDA: 020753

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AROMASIN	exemestane	TABLET;ORAL	020753	NDA	Pharmacia & Upjohn Company LLC	0009-7663	0009-7663-04	30 TABLET in 1 BOTTLE (0009-7663-04)
AROMASIN	exemestane	TABLET;ORAL	020753	NDA AUTHORIZED GENERIC	Greenstone LLC	59762-2858	59762-2858-1	30 TABLET, SUGAR COATED in 1 BOTTLE (59762-2858-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Oct 21, 1999	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020753

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	AROMASIN	exemestane	TABLET;ORAL	020753-001	Oct 21, 1999	See Plans and Pricing	See Plans and Pricing
Pfizer	AROMASIN	exemestane	TABLET;ORAL	020753-001	Oct 21, 1999	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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